Spherix Health Sciences consultants are credentialed professionals with the experience, expertise, and management skills to provide clients unparalleled efficient and effective support.
Claire L. Kruger, Ph.D., D.A.B.T.
CEO, COO, and Director of Health Sciences
Dr. Claire Kruger is a toxicologist with more than 20 years of consulting experience. Her primary area of expertise is in foods, consumer products and pharmaceuticals, where she provides scientific, regulatory, and strategic support to clients in both the U.S. and international regulatory arenas. She has conducted toxicity evaluations of food contaminants, as well as health risk assessments and exposure assessments of drugs, cosmetics, and pesticides. Dr. Kruger’s clients include food, drug, and dietary supplement manufacturers, agricultural producers, biotechnology companies, trade associations, and law firms.
Robert A. Lodder, Ph.D.
President
In addition to his position at Spherix, Dr. Lodder is a professor of Pharmaceutical Sciences at the College of Pharmacy, University of Kentucky Medical Center. He was also appointed by the Food and Drug Administration to serve on their Process Analytical Technologies (PAT) subcommittee, which aims to revolutionize the pharmaceutical industry by replacing the GMP standards under which drugs have been released for the past 40 years with new, science-based PAT methods. Dr. Lodder has conducted mathematical studies aimed at solving the "false-sample" problem and the results have been applied to pharmaceutical quality control and the detection of product tampering in foods and pharmaceuticals.
A. Wallace Hayes, Ph.D., D.A.B.T.
Principal Advisor
Dr. Hayes is a toxicologist with over 30 years of experience in industry and academics. Dr. Hayes also holds an appointment with Harvard School of Public Health. Previously, Dr. Hayes held the position of Corporate Toxicologist for RJR Nabisco with responsibility for all regulatory and toxicology issues related to the safety of ingredients and food contact substances for food and drink products worldwide. Subsequently, as Vice-President of Corporate Product Integrity at the Gillette Company, he had management responsibility for the safety evaluation of a variety of consumer products, plant safety, environmental stewardship, and quality control, responsible for regulatory and toxicology issues worldwide.
Randy Brown
Chief of Operations
With nearly 20 years in the pharmaceutical industry, Mr. Brown’s primary area of expertise is in managing large global clinical trials. His previous positions at companies including Pfizer, Eli Lilly, and Genentech have focused on operations management. He has experience managing global trials in roughly 30 different countries including new emerging areas such as India and Eastern Europe. Mr. Brown led the efforts for the Spherix Phase 3 study in India where more than 500 patients were screened across 24 sites, in less than 30 days.
Ram Nimmagudda, Ph.D.
Business Director
Dr. Nimmagudda currently heads Business Operations for Spherix. With nearly 20 years in the nutrition industry in various capacities, Dr. Nimmagudda brings the knowledge of industry from discovery through commercialization of products. Dr. Nimmagudda has mainly worked with bioactive ingredients, probiotics and FMCG products while holding positions around the world in R&D, Technical Sales, Operations/Supply Chain and Business Development.
Yongming Lu, Ph.D.
Senior Science Director
Dr. Yongming Lu has more than 18 years of experience in analytical chemistry, biochemical and environmental engineering, and has expertise is in the development of upstream and downstream biotechnology processes. His specialized areas of study and practical application include microbial, mammalian and plant cell culture, immobilization technology, and bioreactor and bio-reaction kinetics. Dr. Lu has extensive experience in the evaluation of production processes as they relate to the evaluation of safety for production of foods, pharmaceuticals, nutraceuticals, and cosmetics.
Nancy L. Booth, Ph.D.
Senior Science Consultant
Dr. Nancy Booth is a Science Consultant at Spherix. She has diverse training in the areas of organic/bio-organic chemistry, pharmacognosy, natural products, dietary supplements, and cancer. Her primary area of expertise is in the scientific evaluation of botanical dietary supplements, development of high-throughput screening assays, and drug discovery. She also has experience in anticancer signal transduction pathways utilizing death receptors, estrogenic phytochemicals, and optimizing in vitro bioassays for use with natural products.
Roger A. Clemens, Ph.D.
Senior Consultant
Dr. Roger A. Clemens is a consultant with Spherix, providing strategic, scientific and regulatory guidance for clients. He is currently Associate Director of the Regulatory Science program and Adjunct Professor of Pharmacology and Pharmaceutical Sciences within the USC School of Pharmacy, and is the consulting Scientific Advisor for ETHorn. He has published more than 50 original manuscripts in nutrition and food science, participated in more than 200 invited domestic and international lectures, and served as an expert panel member for the food industry, scientific organizations, trade associations and regulatory agencies in the U.S. and Canada.
Ronald S. Slesinski, Ph.D.
Senior Consultant
Dr. Ronald Slesinski assists Spherix with respect to food, chemical and pesticide companies with a wide range of regulatory and scientific issues, including pesticide residue and analytical studies, antimicrobial and bio-pesticide registrations with EPA and preparation of safety profiles for pesticides, food additives and drug products. He is a board-certified toxicologist with over 30 years of experience in academia, toxicology testing and regulatory affairs.
Susan Phillips, M.S.
Science Consultant
Susan Phillips has been a scientific consultant since 1994 in the Washington DC area. She has provided scientific, regulatory and strategic support to clients concerning product development and the safety evaluation of direct and indirect food additives, GRAS substances, industrial chemicals, and pesticides. Ms. Phillips’ technical support includes the evaluation of biochemistry, organic chemistry and toxicity data based on actual laboratory expertise.